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Results: 1-10 of 85

FDA plans to finalize generic drug labeling rule by December 2014
  • Shook Hardy & Bacon LLP
  • USA
  • June 19 2014

According to the Department of Health and Human Services' semiannual agenda, the U.S. Food and Drug Administration (FDA) plans to issue a final rule


Public Citizen sues FDA, claims warnings on anti-acid drug are inadequate
  • Shook Hardy & Bacon LLP
  • USA
  • May 8 2014

Advocacy organization Public Citizen has sued the U.S. Food and Drug Administration (FDA), seeking a court order requiring the agency to issue a


FDA sued for failure to prohibit mercury dental fillings
  • Shook Hardy & Bacon LLP
  • USA
  • March 13 2014

A number of non-profit organizations and individuals have filed a declaratory action against the U.S. Food and Drug Administration (FDA), claiming


Biomedical device maker enters plea, failed to provide information to FDA
  • Shook Hardy & Bacon LLP
  • USA
  • February 6 2014

San Diego-based Valor Medical, Inc., a biomedical device manufacturer, and four of its employees have reportedly pleaded guilty to counts of failing


FDA modifies list of recognized standards
  • Shook Hardy & Bacon LLP
  • USA
  • February 6 2014

The U.S. Food and Drug Administration (FDA) has announced the availability of its publication, "Modifications to the List of Recognized Standards


FDA seeks to create labeling parity for generic drug makers
  • Shook Hardy & Bacon LLP
  • USA
  • November 27 2013

The U.S. Food and Drug Administration (FDA) has issued a proposed rule that would speed the dissemination of new safety information about generic


Drug compounding oversight bill advances in House
  • Shook Hardy & Bacon LLP
  • USA
  • October 3 2013

The U.S. House of Representatives has reportedly passed by voice vote a bill (H.R. 3204) to strengthen the Food and Drug Administration's (FDA's


FDA publishes guidance on wireless technology in medical devices
  • Shook Hardy & Bacon LLP
  • USA
  • August 22 2013

The Food and Drug Administration (FDA) has published guidance titled "Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry


FDA proposes pilot program to test automated form for NDA submissions
  • Shook Hardy & Bacon LLP
  • USA
  • May 9 2013

The Food and Drug Administration (FDA) has announced a pilot program "to test an XML (extensible markup language)-enabled Adobe PDF form, Form FDA


FDA proposes regulations for stand-alone symbols on medical devices
  • Shook Hardy & Bacon LLP
  • USA
  • April 25 2013

The Food and Drug Administration (FDA) has proposed revising medical device and biological product labeling regulations "to explicitly allow for the